Selected Accomplishments

Awarded Pharma Tech Outlook's Top Pharma Consulting Services Provider of 2023.
Helped multiple start-ups plan and execute on their first IND filing.
Critical role in bringing Linzess (linaclotide) to patients. Part of the R&D program team from discovery, clinical development, approval, & post-marketing requirements. www.linzess.com
Wide-ranging experience interacting with FDA, from Pre IND, Type C and Pre-NDA meetings to label negotiations and post-marketing requirement discussions.
Extensive experience with regulatory filings, including INDs (> 30), CTDs, NDAs, and MAAs (small molecules, peptides and bacterial biotherapeutics).
Significant strategic experience at senior/executive management level, including externally facing to Board of Directors, Scientific Advisory Boards, and partners.
Strong scientific reputation in analytical pharmacology, biochemistry, bioanalytical chemistry, drug metabolism, in vitro ADME, PK/TK, clinical pharmacology and pharmacodynamics.

Joined Ironwood (formerly Microbia) as a startup and helped to successfully create a public company with over 500 employees & >$2B valuation.

Led initial effort to build essential drug discovery capabilities including developing initial people system, processes and supporting technology.

Founded and led multiple functional groups (Secondary Assays, Bioanalytical Sciences, Analytical Pharmacology, DMPK).

Oversaw effort to design and build multiple multimillion-dollar LC/MS instrumentation laboratories.